i-Stat BNP cartridges recallZ-2170-2012 · Abbott Point Of Care Inc. · initiated Feb 1, 2012
Class II Terminated All recalls posted in August 2012
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Abbott Point Of Care Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The frequency of suppressed results for i-Stat cTnl, BNP and CK-MP cartridges is affected by atmospheric pressure.
FDA root cause category: Device Design
What the company is doing
Abbott Point of Care (APOC) sent an URGENT RECALL NOTICE dated February 2012 to all affected customers via e-mail and also contacted by phone. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised that if their facility was performing testing at more than approximately 7500 feet above sea level, they should have an alternate test method available should they experience an issue. If they have forwarded any cartridges to another facility, they should provide a copy of the Urgent Recall Notice to them. For questions customers were instructed to call 800-366-8020, Option 1 or contact their Abbott Point of Care representative. For questions regarding this recall call 609-454-9000.
Recall details
- Recall number
- Z-2170-2012
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Feb 1, 2012
- Posted by the FDA
- Aug 9, 2012
- Recalling firm
- Abbott Point Of Care Inc.
- Quantity
- 1,004,200 cartridges US; 54,200 cartridges OUS
- Product code
- NBC
- FDA submissions
- K053597
- Distribution
- Worldwide Distribution - USA including AZ and CO and internationally to Argentina, Australia, Austria, Belgium, Bolivia, Brazil, Chile, China, Colombia, Costa Rica, Dominican Republic, El Salvador, Finland, France, Georgia, Germany, Greece, Honduras, Hong Kong, India, Ireland, Italy, Korea, Kuwait, Mauritius, Mexico, Netherland (Antilles), Nigeria, Norway, Oman, Paraguay, Peru, Poland, Portugal, Qatar, Russia, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, R.O.C., Thailand, UAE, United Kingdom, and Yemen.
Product description
i-Stat BNP cartridges Abbott Point of Care Inc. The i-Stat BNP test is an in vitro diagnostic test for the quantitative measurement of B-type Natriuretic Peptide (BNP) in whole blood or plasma samples using EDTA as the anticoagulant. BNP measurements can be used as an aid in the diagnosis and assessment of the severity of congestive heart failure.
Code information (models, lots, serial numbers)
List number 06F30-01, 06F30-02, 03P93-25, 600-9010-25 All lots
Other devices under the same FDA submission
1 device cleared under K053597 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- i-STAT 03P93-25Abbott Point Of Care Inc. · TEST,NATRIURETIC PEPTIDE2 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 62533).
- Z-2169-2012 · Terminatedi-Stat cTnl cartridges Abbott Point of Care Inc. The i-Stat cTnl test is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I in heparinized whole b…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page